Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to no specified methods
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Not specified
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol
EC Number:
216-971-0
EC Name:
3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol
Cas Number:
1709-70-2
Molecular formula:
C54H78O3
IUPAC Name:
3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three male and 3 female New Zealand White rabbits (obtained from H.A.R.E. Rabbits for Research, Hewitt, New Jersey) were used for this study. The rabbits weighed from 2300 to 2813 grams at the beginning of the study. The rabbits were individually housed in hanging wire-mesh cages in temperature and humidity controlled quarters. They were maintained in accordance with the recommendations contained in H.E.W. Publication No. 74-23 (N.I.H.) entitled "Guide for the Care and "Ose of Laboratory Animals". The animals were conditioned for a period of 20 days prior to study initiation. Water and Purina Rabbit Chow were available ad libitum.

Test system

Vehicle:
not specified
Controls:
other: left eye untreated
Amount / concentration applied:
The rabbits received 100 milligrams of the test material
Duration of treatment / exposure:
Not specified
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males
3 females
Details on study design:
Prior to test material administration, the eyes of each rabbit were examined with ultraviolet light following instillation of one drop of a 2.0 percent sodium fluorescein solution. Rabbits exhibiting corneal lesions were discarded.
The rabbits received 100 milligrams of the test material. The test material was placed into the cupped conjunctival sac of the right eye of each rabbit following which the eyelids were gently held together for one second. The left eye served as the untreated control for each rabbit. None of the rabbits received a washout.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Remarks on result:
other: Opacity
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
> 0 - < 1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Opacity
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48, 72 hours & 7 days
Score:
0
Max. score:
0
Remarks on result:
other: Opacity
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Remarks on result:
other: Area
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
> 0 - < 1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Area
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48, 72 hours & 7 days
Score:
0
Max. score:
0
Remarks on result:
other: Area
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
> 0 - < 1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours
Score:
> 0 - < 1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48, 72 hours & 7 days
Score:
0
Max. score:
0
Remarks on result:
other: Irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
> 1 - < 2
Max. score:
1.5
Reversibility:
fully reversible
Remarks on result:
other: Redness
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
> 1 - < 2
Max. score:
2.5
Reversibility:
fully reversible
Remarks on result:
other: Redness
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
> 0 - < 1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Redness
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
> 0 - < 1
Max. score:
0.5
Reversibility:
fully reversible
Remarks on result:
other: Redness
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
0
Remarks on result:
other: Redness
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
> 1 - < 2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours
Score:
> 0 - < 1
Max. score:
1.5
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 hours
Score:
> 0 - < 1
Max. score:
0.5
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hours & 7 days
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
> 1 - < 2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: Discharge
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
> 0 - < 1
Max. score:
1.5
Reversibility:
fully reversible
Remarks on result:
other: Discharge
Irritant / corrosive response data:
Not specified

Any other information on results incl. tables

Primary Eye Irritation Study in the Albino Rabbit – Group Observations

 

Observations

 

Examination Interval (No. Positive/No. Dosed)

Hours

Day

1

24

48

72

7

DRAIZE SCORING VALUES

Cornea

Cornea Normal

6/6

3/6

5/6

6/6

6/6

Dulling Normal Corneal Luster

 

2/6

1/6

 

 

Corneal Opacity

Very slight

 

1/6

 

 

 

Slight

 

 

 

 

 

Moderate

 

 

 

 

 

Marked

 

 

 

 

 

Iris

Iris Normal

5/6

4/6

6/6

6/6

6/6

Iridal Irritation

1/6

2/6

 

 

 

Conjunctivae

Redness

Normal

 

 

2/6

5/6

6/6

Very slight

 

3/6

2/6

1/6

 

Slight

6/6

2/6

2/6

 

 

Moderate

 

1/6

 

 

 

Marked

 

 

 

 

 

Chemosis

Normal

1/6

2/6

5/6

6/6

6/6

Very slight

4/6

4/6

1/6

 

 

Slight

1/6

 

 

 

 

Moderate

 

 

 

 

 

Marked

 

 

 

 

 

Discharge

Normal

 

5/6

6/6

6/6

6/6

Very slight

1/6

 

 

 

 

Slight

4/6

1/6

 

 

 

Moderate

1/6

 

 

 

 

Marked

 

 

 

 

 

SODIUM FLUORESCENT/ULTRA-VIOLET LIGHT EXAMINATION

 

Negative (normal)

 

---

---

---

6/6

6/6

Positive (corneal injury)

---

---

---

0/6

0/6

OTHER FINDINGS

Clear discharge

6/6

1/6

0/6

0/6

0/6

Blanching, conjunctivae

3/6

0/6

0/6

0/6

0/6

 

Primary Eye Irritation Study in the Albino Rabbit – Group Average Scores

Area

Average Scores (Range)

Period

Hours

Day

1

24

48

72

7

Cornea

A

0

0.2

(0 – 1.0)

0

0

0

B

0

0.5

(0 – 3.0

0

0

0

Score

0

0.5

0

0

0

Iris

A

0.2

(0 – 1.0)

0.3

(0 – 1.0)

0

0

0

Score

1.0

1.5

0

0

0

Conjunctivae

A

1.1

(1.0 – 1.5)

1.1

(0 – 2.5)

0.5

(0 – 1.0)

0.1

(0 – 0.5)

0

B

1.0

(0 – 2.0)

0.7

(0 – 1.5)

0.1

(0 – 0.5)

0

0

C

1.3

(0.5 – 2.0)

0.3

(0 – 1.5)

0

0

0

Score

6.8

4.2

1.2

0.2

0

 

Total scores

7.8

6.2

1.2

0.2

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the data obtained and in accordance with the requirements of the regulations of the Federal Hazardous Substances Act, the test material would not be considered a primary eye irritant
Executive summary:

Based upon the data obtained and in accordance with the requirements of the regulations of the Federal Hazardous Substances Act, the test material would not be considered a primary eye irritant